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ZYLORIC Tablet (2017)

Active ingredients: Allopurinol

Product Name and Form

Zyloric 100 mg Tablets.

Zyloric 300 mg Tablets.

Pharmaceutical form

Tablet.

Each 100 mg tablet is round, white to off-white, biconvex, bisected tablet, debossed with Z1 on one side.

Each 300 mg tablet is round, white to off-white, biconvex, bisected tablet, debossed with Z3 on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses.

Qualitative and Quantitative Composition

Allopurinol 100 mg (Zyloric Tablets).

Allopurinol 300 mg (Zyloric-300 Tablets).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Allopurinol

Allopurinol is a xanthine-oxidase inhibitor. Allopurinol and its main metabolite oxipurinol lower the level of uric acid in plasma and urine by inhibition of xanthine oxidase, the enzyme catalyzing the oxidation of hypoxanthine to xanthine and xanthine to uric acid.

List of excipients

Lactose
Maize Starch
Povidone
Magnesium Stearate
Purified Water

Pack sizes and Marketing

Zyloric 100 mg Tablets: PVC/aluminium foil blister packs of 100 tablets.

Zyloric-300 Tablets: PVC/aluminium foil blister packs (2 strips of 14 tablets).

Marketing authorization holder
Authorization dates

Aspen Pharma Trading Limited 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Zyloric 100 mg Tablets:

Date of first authorisation: 20.03.80
Renewal: 06.06.90
Date of latest renewal: 14.11.95

Zyloric-300 Tablets:

Date of first authorisation: 14.07.80
Renewal: 18.02.91
Date of latest renewal: 25.11.98

Marketing authorization number:

PL 39699/0001 – Zyloric 100 mg Tablets
PL 39699/0002 – Zyloric-300 Tablets